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Imagine having your elbow replaced with an artificial joint only to find out the elbow implant device you received was defective and had to be removed from the market. Unfortunately, that is exactly what happened to patients who received the Synthes elbow replacement device. More than 50,000 of the devices were pulled from shelves across the country leading to many patients filing Depuy elbow implant lawsuits seeking justice.
If you have an elbow implant operation, it can take about two hours to complete the surgical implantation and will require up to a four-day hospital stay. During the operation, your skin, tendons, and bones will be cut, so you will be prescribed medication to manage the pain for a few weeks. You can expect restrictions on what you can do and lift with the affected arm for at least six weeks.
During recovery, you will need physical therapy to strengthen the joint and keep the muscles and tendons flexible while they heal. Still, though an elbow implant should increase your range of motion, it may not be as strong as reliable as your elbow was before the trauma or disease. In fact, there may be activities that you will not be able to do anymore, including activities that put strain on the joint.
50,311 Synthes Elbow Replacement Devices Pulled from Shelves
The FDA announced a Class 2 recall after reports that the device was coming loose at the stem/bone interface. Patients who received the medical device before it was recalled may experience serious injury if it loosens, including:
- bone loss
- chronic pain radiating down the forearm
- flexion issues
- poor movement
- post-operative fractures
- tissue damage
If you received a defective Synthes elbow, you might have to have additional surgeries to remove damaged bone and tissue and fix or replace the elbow implant with a different one. Patients who are forced to endure these injuries and risky revision surgery may be entitled to seek compensation for damages.
Signs Your Device May be Loosening
People who suffer trauma or degenerative disease may need to have their elbow replaced to restore movement and functionality such as being able to straighten and bend and turning the arm in a clockwise/counterclockwise rotation. The Synthes elbow has two main pieces, the stem, which is implanted down into the radius bone of the forearm, and the head, which is secured to the stem by a taper lock mechanism.
Unfortunately, when DePuy recalled the devices, no advice was given to patients nor information regarding the symptoms and signs of loosening issues. This means that patients may not have any idea their stem is loosening from the radius bone until they start to experience pain that may radiate down the forearm.
Interestingly, researchers have found that one of the first noticeable signs of loosening is pain. They say that even when no other signs of loosening are present, the patient may have pain in the radial bone, including those patients in which the stem was implanted without the use of cement. Other signs of loosening may include swelling around the joint and range of motion issues.